BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L

    MDR report key: 14021286 · Received April 6, 2022

    Report

    Report Number
    3005180920-2022-00239
    Event Type
    Injury
    Date Received
    April 6, 2022
    Date of Event
    March 9, 2022
    Report Date
    April 6, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826535
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 10 MARCH 2022: LOT 183015: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUL-2018. EXPIRATION DATE: 2023-07-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON 10 MARCH 2022: LOT 183477: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JUN-2018. EXPIRATION DATE: 2023-06-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT 3 YEARS AND 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY. A HIGHER SEMICONSTRAINED INSERT, A REVISION FEMUR, AND A FLUTED EXTENSION STEM HAVE BEEN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440481 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0410FL 183015 07630030826535

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention